Gleevec Extends Post-Surgery GIST Survival Significantly; Wins Full Adjuvant Approval
This article was originally published in The Pink Sheet Daily
Executive Summary
Patients who took Novartis’ Gleevec for three years after surgery to remove gastrointestinal stromal tumors had a 54% reduction in risk of recurrence and a 55% reduction in risk of death compared to patients who took it for only one year.
You may also be interested in...
Novartis Glivec Make It Through NICE For GISTs With Expanded Label
After a prior rejection, Britain’s NICE has backed Novartis’ Glivec for KIT (CD117)-positive GISTS, even accepting an expanded-treatment duration of three years compared to the original single year.
FDA Cites Gleevec For Promoting Unapproved Indications Three Weeks Before Expanding Label
Notice of violation letter to Novartis from FDA’s Office of Prescription Drug Promotion expresses concern about describing a patient with five-year survival data, a claim that was added to the label the following month.
For Novartis, 2012 Is Set To Be A Bumpy Ride
With the loss of exclusivity for its blockbuster heart drug, Diovan, coming in September, management focused on the company’s long-term prospects during a fourth quarter financial update.